Inotek Pharmaceuticals Corporation Announces Publication of Phase 1 Data for Trabodenoson in Healthy Adult Volunteers in the Journal of Ocular Pharmacology and Therapeutics

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Trabodenoson Safe, Well Tolerated and Resulted in No Dose-related Ocular or Systemic Side Effects

LEXINGTON, Mass.--(BUSINESS WIRE)--Apr. 21, 2016-- Inotek Pharmaceuticals Corporation (the “Company” or “Inotek”) (NASDAQ: ITEK), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for ocular diseases, today announced the Journal of Ocular Pharmacology and Therapeutics (JOPT) has published the results from its Phase 1 dose-escalation trial in healthy adult volunteers of the Company’s lead product candidate, trabodenoson. These results support the ongoing clinical development of trabodenoson as a novel treatment for glaucoma, and follow publication of the Phase 2 study in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), announced on April 11, 2016.

The research article, “A Randomized Phase 1 Dose Escalation Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Trabodenoson in Healthy Adult Volunteers,” presents data showing that ocular doses of trabodenoson up to 3,200 µg per eye were safe and well tolerated both in the eye and systemically in healthy adult volunteers. Trabodenoson is a wholly-owned, first-in-class selective adenosine mimetic designed to lower intraocular pressure (IOP) through its action at the trabecular meshwork (TM), the site of natural IOP regulation.

“Inotek continues to build a compelling body of safety and efficacy data for trabodenoson as a potential novel approach for the treatment of glaucoma,” said Rudolf Baumgartner, M.D., Chief Medical Officer of Inotek. “Notably, the data from this multi-dose Phase 1 trial showed no dose-related ocular or systemic side effects even when administered at higher doses than those being evaluated in the ongoing Phase 3 trial, MATrX-1.”

“We believe the good-ocular tolerability of trabodenoson may stem, in part, from its structural similarity to naturally occurring adenosine. By activating the A1 adenosine receptor, and enhancing part of the intrinsic IOP regulating process of the trabecular meshwork rather than changing the fundamental dynamics of pressure regulation in the eye, we believe trabodenoson’s mechanism of action carries a lower risk of unintended side effects with long term chronic use in patients with glaucoma,” commented William McVicar, Ph.D., Chief Scientific Officer of Inotek.

About the Phase 1 Study

The Phase 1 study was a randomized, double-masked, placebo-controlled dose escalation study designed to characterize the systemic and local ocular safety and tolerability of trabodenoson delivered via topical ophthalmic dosing. Overall, 70 adult healthy volunteers were enrolled in this USA-based trial. Key exclusion criteria included best-corrected visual acuity worse than 20/60 in either eye, active eye disease and other factors.

ARTICLE LINK: http://online.liebertpub.com/doi/pdf/10.1089/jop.2015.0147

ARTICLE REFERENCE: Journal of Ocular Pharmacology and Therapeutics. April 2016, ahead of print. doi: 10.1089/jop.2015.0147. Study authors; Alan Laties1, Cadmus C. Rich2, Randall Stoltz3, Vernon Humbert4, Chaim Brickman2, William McVicar2, and Rudolf A. Baumgartner2.

1Scheie Eye Institute, Philadelphia, Pennsylvania.

2Inotek Pharmaceuticals Corporation, Lexington, Massachusetts.

3Covance Global Clinical Pharmacology, Evansville, Indiana.

4Evansville Heart Center, Evansville, Indiana.

About Inotek Pharmaceuticals Corporation

Inotek is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases. The Company’s lead product candidate, trabodenoson, is a first-in-class selective adenosine mimetic currently in Phase 3 development. Trabodenoson was developed in Inotek’s laboratories and is designed to restore the eye’s natural pressure control mechanism. Additionally, the Company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases. For more information, please visit http://inotekpharma.com/. The inclusion of our website address here and elsewhere in this press release does not include or incorporate by reference the information on our website into this press release.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. These forward-looking statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Inotek Pharmaceuticals Corporation

Inotek Pharmaceuticals Corporation
Claudine Prowse, Ph.D.
Vice President, Strategy and Investor Relations Officer
cprowse@inotekpharma.com